Gastric Emptying Time in Traumatic Injuries

Gastric Point-of-care Sonography with Focus on Gastric Emptying Time in Patients with Traumatic Injuries. a Prospective Observational Study

The investigators plan to do serial sonographic examinations of the gastric antrum (quantity, quality) to estimate the gastric emptying time and dependant factors after traumatic injurys.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia; Regurgitation; Gastric Ultrasound; Trauma Patients; Sonography; Point of Care Ultrasound (POCUS); Pulmonary Aspiration During Anesthetic Induction
• Intervention / Treatment: Diagnostic test: Gastric ultrasound

Detailed Description

The investigators plan to do serial sonographic examinations of the gastric antrum (quantity, quality) in patients suffering from a relevant traumatic injury. Patients which are admitted to the emergency department with a corresponding history are considered for inclusion. Patient with life-threatening injuries are excluded. After inclusion, the investigators plan to carry out gastric ultrasound (POCUS) all 2 hours until the operative treatment (maximal 5 examinations). To identify factors which may be correlated with delayed gastric emptying several demographic and patient related factors are collected.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Switzerland
  • Winterthur, Switzerland, 8401
    • Recruiting
    • Kantonsspital Winterthur
    • Contact: Roman Meierhans, resident; Phone Number: 052 266 48 46; Email: Roman.Meierhans@ksw.ch
    • Contact: Sascha Bättig, resident
    • Contact: Caveh Madjdpour, chief

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients admitted to the emergency department with a relevant traumatic injury

Description

Inclusion Criteria:

• relevant traumatic injury

Exclusion Criteria:

• life-threatening traumatic injury (immediate treatment is necessary)
• Underage
• Known pregnancy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sonographic quality/quantity of the gastric antrum	Quality of the gastric content (empty, fluid, solid or mixed fluid/solid) and quantity of the gastric content in ml, measured in 2 hour time intervals	2 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain-scale	Evaluate pain using the VAS Scale 0-10 (Visual Analog Scale)	2 hour
Analgetics	Evaluate need of analgetics	2 hour
Stress, activation of sympathic nerve system	Evaluate stress on a VAS 0-10 (Visual Analog Scale)	2 hour

Collaborators and Investigators

• Sponsor: Kantonsspital Winterthur KSW

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 14, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: anesthesia; aspiration; gastric ultrasound; point of care ultrasound; trauma patients
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: POCUS 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No